Business
Aquestive Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update: AQST-108 Progress Remains On Track; Libervant PDUFA Goal Date Approaches
Generated 59% year-over-year revenue growth for Sympazan®(clobazam) FDA completed safety review of IND for AQST-108 (epinephrine) and approved commencement of
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Generated 59% year-over-year revenue growth for Sympazan®(clobazam) FDA completed safety review of IND for AQST-108 (epinephrine) and approved commencement of first planned pharmacokinetics (PK) clinical trials Continues to advance Libervant™ (diazepam) through FDA review and on-going inspection process of manufacturing and clinical investigational sites Ongoing process for potential monetization of royalty rights in KYNMOBI™ (apomorphine) continuesRe-affirms full year 2020 financial guidance Hosts conference call at 8:00 a.m. ET on August 5, 2020 WARREN, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today reported financial results for the second quarter ended June 30, 2020 and provided an update on recent developments in its business. \n Keith J. Kendall, President and Chief Executive Officer of Aquestive, stated, “While continuing to navigate the health crisis caused by the COVID-19 pandemic and, to the best of our ability, fulfilling our responsibility to keep our colleagues and neighbors safe, we are advancing the important work of the Company, as expected, and ensuring the medications our patients depend on each day remain available to them without interruption. We are pleased that Sympazan continued its commercial growth during the second quarter. Also, in July 2020, the FDA accepted our IND for AQST-108, our drug candidate in development to deliver systemic epinephrine for the treatment of anaphylaxis, and we are progressing toward commencing our planned PK trials expected later in the third quarter of this year. Concurrently, we are continuing to advance through the FDA review process for our product candidate, Libervant™ (diazepam) Buccal Film for the management of seizure clusters, including providing information to the agency, responding to its information requests and working with the agency on its inspection of our manufacturing and clinical investigational sites. With the commercial foundation we have built for Sympazan, we will be prepared to launch Libervant quickly, if approved by the FDA for U.S. marketing access. The formal process for a potential monetization of our KYNMOBI royalty asset is ongoing.” Propr...